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UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

A Prospective, Multi-centre, Single-blinded Study of UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06232538
Enrollment
1
Registered
2024-01-30
Start date
2024-01-01
Completion date
2026-08-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder Cancer

Keywords

diagnosis

Brief summary

Copy number variation(CNV) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CNV is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CNV of the DNA extracted from bile samples in gallbladder seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with gallbladder cancer. CNV can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. The investigators here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CNV thus helping diagnose gallbladder cancer and assessing follow-up.

Interventions

DIAGNOSTIC_TESTThe level of CNV

The extracted DNA from bile will be analyzed by UCAD to determine the level of CNV. And the patient will be followed more than 1 year.

Sponsors

Shanghai Zhongshan Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
Changhai Hospital
CollaboratorOTHER
Shanghai Changzheng Hospital
CollaboratorOTHER
Eastern Hepatobiliary Surgery Hospital
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
Jiangsu Provincial People's Hospital
CollaboratorOTHER
Third Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
First Affiliated Hospital of Zhejiang University
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Second Hospital of Jilin University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Southwest Hospital, China
CollaboratorOTHER
Affiliated Hospital of North Sichuan Medical College
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with gallbladder disease and planned to undergo surgery. * Male or female patients aged \>= 18 years. * Participants signed informed consent form.

Exclusion criteria

* Participants had other tumor expect gallbladder cancer

Design outcomes

Primary

MeasureTime frameDescription
UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%2025Ultrasensitive chromosomal aneuploidy detection (UCAD) uses low-coverage whole-genome sequencing technology to detect DNA chromosomal instability in samples. By detecting DNA extracted from patients' bile and blood, bioinformatics can be used to analyze the differences in CNV between benign and malignant gallbladder diseases, and a prediction model for gallbladder cancer.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026